MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	RMT281414
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2014, the patient was treated for an unknown issue.The physician implanted two gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2023, a type ia endoleak was detected.The physician is unsure of the cause of the endoleak.A reintervention is planned.Images are available.
Additional Manufacturer Narrative
Adverse event problem: code c19 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications; code d12 ¿ according to the gore® excluder® aaa endoprosthesis featuring c3® delivery system instructions for use, adverse events with may occur and/or require intervention including, but not limited to, endoleak.Images were returned.The imaging evaluation performed by a clinical imaging specialist showed the following: one time point available for evaluation: post-implantation cta dated 2/20/2023; there appears to be a ~73º aortic angulation distal to the right renal artery; the length from the right renal artery to the proximal circumferential device appears to be ~15mm by centerline length; aortic diameter just distal to the right renal artery appears to be 26.7mm; aortic diameter ~8mm distal to the right renal artery appears to be 29.5mm; aortic diameter 15mm distal to the right renal appears to be 33.9mm; images show lack of proximal device apposition and contrast is visualized outside the proximal end of the device pooling in the sac.These findings confirm a proximal type i endoleak.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16619120
• Report Number: 2953161-2023-01170
• Device Sequence Number: 7118107
• Product Code: MIH
• UDI-Device Identifier: 00733132610716
• UDI-Public: 00733132610716
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: RMT281414
• Device Catalogue Number: RMT281414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/27/2023
• Date Device Manufactured: 01/07/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male